Pharmaceutical Company Lawyer Charged with Obstruction and Making False Statements

WASHINGTON, Nov. 9, 2010 – An attorney for a major
pharmaceutical company was charged with obstruction and making
false statements, the Justice Department announced today. Lauren
Stevens of Durham, N.C., was charged with one count of obstructing
an official proceeding, one count of concealing and falsifying
documents to influence a federal agency, and four counts of making
false statements to the Food and Drug Administration (FDA).

The indictment states that in October 2002, the FDA asked for
information about the company’s promotion of a prescription
drug, as part of an inquiry into whether the drug was being
promoted for uses that had not been approved by the FDA. Data
demonstrating a drug’s safety and efficacy for a particular
use is required for FDA approval. Federal law prohibits the
marketing or promotion of drugs for unapproved – or
"off-label" – uses.

The indictment alleges that, in response to the FDA’s
inquiry, Stevens signed and sent a series of letters from the
company to the FDA that falsely denied that the company had
promoted the drug for off-label uses, even though she knew, among
other things, that the company had sponsored numerous programs
where the drug was promoted for unapproved uses. The indictment
alleges that Stevens knew that the company had paid numerous
physicians to give promotional talks to other physicians that
included information about unapproved uses of the drug. According
to the indictment, the company paid one such physician to speak at
511 promotional events in 2001-2002 and another physician to speak
at 488 such events during that time period.

The indictment also alleges that Stevens did not provide the FDA
with slide sets used by the physicians who were paid by the company
to promote the drug, even though the FDA had asked for the slide
sets and Stevens had previously promised to obtain and provide the
FDA with such materials. The indictment alleges that a legal
memorandum was prepared for Stevens that set forth the "pros" and
"cons" of producing the slide sets to the FDA. According to the
indictment, one of the "cons" was that the slide sets would provide
"incriminating evidence about potential off-label promotion of [the
drug] that may be used against [the company] in this or in a future
investigation." Instead of providing the requested slide sets to
the government, Stevens represented that the company’s
responses to the FDA’s requests was "final" and
"complete."

"Where the facts and law allow, the Justice Department will
pursue individuals responsible for illegal conduct just as
vigorously as we pursue corporations," said Tony West, Assistant
Attorney General for the Civil Division of the Department of
Justice. "Criminal charges are appropriate when false statements
such as those alleged here are made to the FDA."

"There is a difference between legal advocacy based on the facts
and distorting the facts to cover up the truth," said Carmen Ortiz,
U.S. Attorney for the District of Massachusetts. "Federal agencies
such as the FDA cannot protect the public health if the entities
and individuals they regulate provide false information and conceal
the true facts."

The charges were filed in the District of Maryland, where the
FDA is located. The case is being prosecuted by the Civil
Division’s Office of Consumer Litigation and U.S.
Attorney’s Office for the District of Massachusetts. The case
is being investigated by agents from the Office of Inspector
General of the Department of Health and Human Services, the FBI,
the FDA’s Office of Criminal Investigations and the Defense
Criminal Investigative Service (DCIS).

"This indictment demonstrates that those who purposely subvert
the regulatory functions of the FDA through false statements and
misleading information will be held accountable for their
deception," stated Dara Corrigan, FDA's Associate Commissioner for
Regulatory Affairs. "We commend the efforts of the Department of
Justice and the other law enforcement agencies that are vigorously
pursuing the prosecution of this matter."

"Lauren Stevens allegedly misled investigators intentionally and
failed to comply with our request for documents," said Susan J.
Waddell, Special Agent in Charge of the Department of Health and
Human Services Office of Inspector General’s Boston
region.

"This indictment shows that we will investigate those
responsible for unlawful acts done on a company's behalf. When
individual employees are identified, they will be held accountable
for their illegal activity. Individual employees now know that
concealing information from the government, obstructing
investigative activity and making false statements to federal
investigators will be investigated and prosecuted," said Richard
DesLauriers, Special Agent in Charge, FBI, Boston Division.

"This indictment demonstrates that misleading federal officials
is a serious offense that will not be tolerated," said
Leigh-Alistair Barzey, DCIS Resident Agent in Charge. " DCIS will
continue to partner with other federal agencies, such as the FDA,
in an effort to protect the DoD's TRICARE health plan, which
provides medical care for America's military members and their
families."

Each of the obstruction charges carries a maximum penalty of 20
years in prison. Each of the false statement counts carry a maximum
penalty of five years in prison. Charges contained in the
indictment are simply accusations, and not evidence of guilt.

The pharmaceutical company for whom Stevens worked has not been
charged with a crime and was not identified in the indictment.